PROSPAN

PROSPAN Cough Effervescent Tablets

Important notes (mandatory information)

Prospan Cough Effervescent Tablets. Active ingredient: Ivy leaf dry extract. Areas of application: as an expectorant for productive coughs.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Prospan Cough Effervescent Tablets
Active ingredient: Ivy leaf dry extract

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, Prospan Cough Effervescent Tablets must be used as directed to ensure the best possible treatment results.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve after 7 days, you must see a doctor.
• If any of the side effects listed here affect you significantly or if you notice any side effects not listed in this package leaflet, please inform your doctor or pharmacist.

This package leaflet contains

1. WHAT ARE PROSPAN COUGH EFFERVESCENT TABLETS AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING PROSPAN COUGH EFFERVESCENT TABLETS?
3. HOW TO TAKE PROSPAN COUGH EFFERVESCENT TABLETS?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD PROSPAN COUGH EFFERVESCENT TABLETS BE STORED?
6. FURTHER INFORMATION

1. WHAT ARE PROSPAN COUGH EFFERVESCENT TABLETS AND WHAT ARE THEY USED FOR?

Prospan Cough Effervescent Tablets are a herbal medicine for catarrhal respiratory tract conditions. Prospan Cough Effervescent Tablets are used as an expectorant for productive coughs. Note: If symptoms persist or if shortness of breath, fever, or purulent or bloody sputum occur, a doctor should be consulted immediately.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING PROSPAN COUGH EFFERVESCENT TABLETS?

Prospan Cough Effervescent Tablets must not be taken if you are hypersensitive (allergic) to the active ingredient or any of the other ingredients of the medicine. In case of fructose intolerance, treatment should only be carried out after consulting a doctor.

Special care should be taken when taking Prospan Cough Effervescent Tablets

Children

Prospan Cough Effervescent Tablets are not intended for use in children under 6 years of age.

When taking Prospan Cough Effervescent Tablets with other medicines

No studies have been conducted. No interactions have been reported to date. Please inform your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines.

Pregnancy and breastfeeding

The medicine should not be used during pregnancy and breastfeeding due to insufficient studies.

Driving and operating machinery

No special precautions are required.

Important information about certain other ingredients of Prospan Cough Effervescent Tablets

One effervescent tablet contains 6.58 mmol (or 151.33 mg) of sodium. If you are on a low-salt diet, you should take this into account. The flavouring contains lactose. 1 effervescent tablet contains 29.7 mg of lactose. Therefore, please only take Prospan Cough Effervescent Tablets after consulting your doctor if you know that you suffer from a sugar intolerance.

3. HOW TO TAKE PROSPAN COUGH EFFERVESCENT TABLETS?

Always take Prospan Cough Effervescent Tablets exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is

Age	Single dose	Total daily dose
Adults and adolescents from 12 years of age	Morning: 1 effervescent tablet equivalent to 65 mg of ivy leaf dry extract	1 time 1 and 1 time 1/2 effervescent tablet equivalent to 97.5 mg of ivy leaf dry extract
Evening: VS effervescent tablet equivalent to 32.5 mg of ivy leaf dry extract
Children from 6 – 12 years of age	1/2 effervescent tablet equivalent to 32.5 mg of ivy leaf dry extract	2 times 1/2 effervescent tablet equivalent to 65 mg of ivy leaf dry extract

Method of administration

Effervescent tablets, to be taken after dissolving. The effervescent tablets are divisible. The effervescent tablets are dissolved in a glass of water (approx. 100 - 200 ml) and taken in the morning and evening. Both hot and cold water can be used for dissolving.

Duration of use

The duration of treatment depends on the type and severity of the clinical picture; it should generally be 1 week. However, if the symptoms persist for longer than 1 week, medical advice should be sought. Please talk to your doctor or pharmacist if you have the impression that the effect of Prospan Cough Effervescent Tablets is too strong or too weak.

If you have taken more Prospan Cough Effervescent Tablets than you should

No more Prospan Cough Effervescent Tablets should be taken per day than stated in the dosage instructions or prescribed by your doctor. Taking significantly higher amounts (more than three times the daily dose) can cause nausea, vomiting and diarrhoea. In this case, you should consult your doctor.

If you forget to take Prospan Cough Effervescent Tablets

Do not take double the dose the next time, but continue taking as prescribed by your doctor or as described in the package leaflet.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Prospan Cough Effervescent Tablets can have side effects, although not everybody gets them.

The following frequency information is used to assess side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Possible side effects

After taking ivy-containing medicines, allergic reactions such as shortness of breath, swelling, skin redness, itching may occur. The frequency is not known. In sensitive individuals, gastrointestinal symptoms such as nausea, vomiting, diarrhoea may occur. The frequency is not known.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW SHOULD PROSPAN COUGH EFFERVESCENT TABLETS BE STORED?

Keep out of reach of children! Do not use the medicine after the expiry date which is stated on the folding box and the foil strip! The expiry date refers to the last day of the month.

6. FURTHER INFORMATION

What do Prospan Cough Effervescent Tablets contain?
The active ingredient is: Ivy leaf dry extract 1 effervescent tablet contains 65 mg of dry extract from ivy leaves (5 - 7.5 : 1). Extraction solvent: Ethanol 30 % (m/m). The other ingredients are: Anhydrous citric acid (Ph.Eur.), sodium hydrogen carbonate, sodium carbonate, mannitol (Ph.Eur.), simethicone, saccharin sodium 2 H2O, sodium cyclamate, sodium citrate 2 H2O, sorbitol (Ph.Eur.), medium-chain triglycerides, macrogolglycerol hydroxystearate (Ph.Eur.), flavouring. 1 effervescent tablet contains 382 mg of carbohydrates (equivalent to 0.03 BE).

What do Prospan Cough Effervescent Tablets look like and contents of the pack

Prospan Cough Effervescent Tablets are available in original packs of 20 effervescent tablets.

Pharmaceutical entrepreneur and manufacturer

Engelhard Arzneimittel GmbH & Co. KG
Herzbergstraße 3
61138 Niederdorfelden
Tel.: 06101 / 539 - 300
Fax: 06101 / 539 - 315
Internet: http://www.engelhard-am.de
E-Mail: info@engelhard-am.de

This package leaflet was last revised in February 2016.

Active ingredient: Ivy leaf dry extract. Areas of application: as an expectorant for productive coughs.